Presentation Overview

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1 Regulatory Issues For Iowa Dentists May 5, 2017 REBECCA A. BROMMEL BrownWinick 666 Grand Avenue, Suite 2000 Des Moines, IA Telephone: Facsimile: Presentation Overview Scope of Practice Expanded Functions Supervision of Dental Hygienists & Dental Assistants Sedation Scope of Practice - Dentists Diagnosing Treatment Planning Determining appropriateness of proposed dental care Publicly profess to be dentist, dental surgeon or skilled in science of dentistry Diagnose, treat or attempt to correct any disease, condition, disorder, lesion, injury, deformity or defect of oral cavity and maxillofacial area (teeth, gums, jaw and associated structures and tissues) 1

2 Scope of Practice Dentists (cont.) Offering to perform, performing or assisting with any phase of any operation incident to tooth whitening, including the instruction or application of tooth whitening materials or procedures at any geographic location North Carolina Board of Dental Examiners v. FTC Scope of Practice Dental Hygienists Educational: individual patients and community groups, training for nurses, school personnel, institutional staff and agencies on promotional, preventative or educational services Therapeutic: oral prophylaxis; periodontal scaling and root planing; removing/polishing hardened excess restorative material; local anesthesia (with permit); administer nitrous oxide; apply or administer medicaments prescribed by dentist for periodontal disease and caries; removal of adhesives Scope of Practice Dental Hygienists (cont.) Preventative: pit and fissure sealants and other medications or methods for periodontal disease and caries, fluoride rinse and sealant programs Diagnostic: review medical and dental histories; perform oral inspection; index disease; preliminary charting of existing dental restorations and teeth; make occlusal registrations for mounting study casts; testing pulp vitality; analyze dietary surveys 2

3 Scope of Practice Dental Hygienists (cont.) Delegation by dentist required for: administration of local anesthesia placement of sealants Removal of plaque, stain, calculus or hard natural or synthetic material except by toothbrush, floss or rubber cup coronal polish Scope of Practice Dental Assistants Procedures for which DA has received training Delegation by dentist based upon best interest of patient Dentist responsible: For determining what aspects can be delegated to DA For all acts performed Scope of Practice Dental Assistants (cont.) Limits on delegation by dentist Diagnosis, examination, treatment planning Prescription for medicaments or drugs Authorization for restorative, prosthodontic or orthodontic appliance Surgical procedures on hard and soft tissues within oral cavity and any other intraoral procedure that results in irreversible alteration Local anesthesia administration Placement of sealants Removal of plaque, stain, or hard natural or synthetic material except by toothbrush, floss or rubber cop coronal polish or removal of calculus Dental radiography unless authorized/permitted Procedures that require skill and professional judgment of dentist 3

4 Scope of Practice Expanded Functions Basic, Level 1 and Level 2 Basic One or more of the duties listed under other Levels (but not all) Level 1 Board approved courses listed on-line Level 2 Only through University of Iowa; entrance exam Board has forms to be completed to obtain certification Can carryover certifications if a DA becomes a hygienist Scope of Practice Expanded Functions (con t) Level 1 for Dental Hygienist: Occlusal registrations Placement and removal of gingival retraction Fabrication and removal of provisional restorations (NOT placement) Applying cavity liners and bases, desensitizing agents and bonding systems Taking of final impressions Can take courses for functions listed under DA Level 1, but not required to be a Hygienist Certified Level 1 Scope of Practice Expanded Functions (con t) Level 1 for Dental Assistant: Occlusal registrations Placement and removal of gingival retraction Fabrication and removal of provisional restorations (NOT placement) Applying cavity liners and bases, desensitizing agents and bonding systems Placement and removal of dry socket medication Placement of periodontal dressings Testing pulp vitality Monitoring of nitrous oxide Taking final impressions Removal of adhesives (by hand instrumentation only) Preliminary charting of existing dental restorations and teeth 4

5 Scope of Practice Expanded Functions (con t) Level 2 for Dental Hygienist and Dental Assistant: Placement and shaping of amalgam following prep of tooth by dentist Placement and shaping of composite following prep of tooth by dentist Forming and placement of stainless steel crowns Taking records for fabrication of dentures and partial dentures Tissue reconditioning (soft reline only) Supervision Generally Type of personnel Type of duty Patient need (new vs. recall) Levels of Supervision Personal = dentist physically present in treatment room Direct = dentist present in facility, but not necessarily in room General = services delegated by dentist to DA or RDH Public Health = dentist delegates duties in public health setting without need for initial exam by dentist 5

6 Supervision of Hygienist Direct: admin of local anesthesia or nitrous oxide new patients (except public health supervision) If dentist believes it is necessary to met individual needs of patient General: all authorized services if dentist has examined first educational, assessment, screening or data collection to prepare prelim records can be done without seeing dentist first Supervision of Hygienist (cont.) Subsequent exams and monitoring, including definitive diagnosis and treatment planning is responsibility of dentist; carried out in reasonable period of time in accordance with professional judgment and individual needs of patient Expanded functions: Delegated and performed under dentist supervision General supervision taking occlusal registrations for purposes of other than mounting study casts Everything else - direct Supervision of RDA Direct: all actions not allowed under general, all expanded functions General: limited to all extraoral duties, dental radiography, intraoral suctioning, use of curing light and intraoral camera Dentist must see patient first (only way to properly delegate for general supervision) Personal supervision if trainee 6

7 Public Health Supervision Hygienist: active Iowa license and 3 years clinical experience Public health settings defined in (1) Assistant: active Iowa registration and 1 year clinical experience Public or private schools, public health agencies, hospitals or armed forces (more limited) Public Health Supervision (cont.) Dentist authorizes and delegates, but dental exam not required in advance Dentist not required to provide future dental treatment to patients served Written agreement requirements Reporting requirements Check Up on your Personnel Are all licenses and registrations current? Are all licenses and registrations on display in office? Are you using the proper level of supervision? Are the services within their scope of practice, including within the level of their expanded function certification? 7

8 Types of Sedation Deep or General Anesthesia Moderate Minimal Nitrous Oxide Inhalation Analgesia Deep Sedation or General Anesthesia controlled state of unconsciousness, produced by a pharmacological agent, accompanied by partial or complete loss of protective reflexes, including inability to independently maintain an airway and respond purposefully to physical stimulation or verbal command Deep Sedation Requirements Dentist s Permit Advanced education program accredited by Commission on Dental Accreditation that provides deep sedation/general anesthesia training Formal training in airway management Minimum 1 year of advanced training in anesthesiology and related academic subjects beyond undergraduate dental school level, training must be Board-approved Completion of peer review evaluation as required by Board Current and successful completion of Advanced Cardiac Life Support Course 8

9 Deep Sedation Requirements Facility Proper Equipment & training on equipment Capnography EKG monitor Positive pressure oxygen Suction Laryngoscope and blades Endotracheal tubes Magill forceps Oral airways Stethoscope Blood pressure monitoring device Pulse oximeter Emergency drugs defibrillator Deep Sedation Requirements Personnel 2 qualified auxiliary personnel in room Capable of reasonably handling procedures, problems and emergencies incident to the administration of general anesthesia Maintain current certification in basic life support and be capable of administering it Moderate Sedation drug-induced depression of consciousness, either by enteral or paraenteral means, during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain patient airway and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. f/k/a conscious sedation 9

10 Moderate Sedation Requirements Dentist s Permit Completion of Board-approved training program that meets ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students minimum 60 hours of instruction and management for at least 20 patients Formal training in airway management Peer review evaluation as may be required by Board Current and successful completion of Advanced Cardiac Life Support course (or PALS if administering to pediatric patients) Alternative option: Completion of accredited residency program that includes formal training and clinical experience in moderate sedation; program is Boardapproved If pediatric or ASA category 3 or 4 patients must have formal training in anesthesia and clinical experience in managing pediatric or ASA category 3 or 4 patients. Moderate Sedation Requirements Facility Proper Equipment Capnography or pretracheal/precordial stethoscope* EKG monitor Positive pressure oxygen Suction Laryngoscope and blades Endotracheal tubes Magill forceps Oral airways Stethoscope Blood pressure monitoring device Pulse oximeter Emergency drugs Defibrillator Moderate Sedation Requirements Personnel 1 qualified auxiliary personnel in room capable of reasonably handling procedures, problems and emergencies incident to the administration of general anesthesia Maintain current certification in basic life support and be capable of administering it 10

11 Deep and Moderate Sedation Additional Issues Permits are biennial; renew same time as license Facility inspections every 5 years Trend: Use of Nurse Anesthetists or Anesthesiologist to provide services in office Request waiver from Board Still need properly equipped facility Nitrous Oxide - Requirements Completion of Board-approved training or equivalent training while in accredited dental school Adequate equipment with fail-safe features and minimum oxygen flow that meets FDA standards Routine inspection, calibration and maintenance on equipment every 2 years; maintain documentation Continuous monitoring of patient by qualified personnel Trained and capable of administering basic life support Nitrous Oxide Hygienists and RDAs Hygienist can administer if: Delegated by dentist, under direct supervision Has Board-approved training or received equivalent while in accredited dental hygiene school Need written office protocol Hygienist or RDA can monitor if: Delegated by dentist, under direct supervision Completed Board-approved course or received equivalent training in accredited school Adverse reactions reported to dentist immediately Dentist dismisses patient at conclusion of procedure 11

12 Minimal Sedation minimally depressed level of consciousness, produced by a pharmacological method, that retains the patient s ability to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal command. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected a/k/a Anti-anxiety premedication or anxiolysis Minimal Sedation Requirements Dentist trained and capable of administering basic life support Adults: Prescribe or administer single enteral drug that is no more than 1.0 times the MRD for unmonitored home use Single supplemental dose of SAME drug may be administered if supplemental dose is no more than ½ of the initial dose and it is not administered until the clinical half-life of initial dose has passed Total aggregate dose cannot exceed 1.5 times MRD on day of treatment Many use nitrous in combo with single enteral drug Combining 2 or more enteral drugs (not including nitrous) or prescribing/administering drugs not recommended for unmonitored home use = moderate sedation Minimal Sedation Requirements (cont.) Pediatric or ASA category 3 or 4 Prescribe or administer single enteral drug that is no more than 1.0 times the MRD for unmonitored home use May administer nitrous oxide for minimal sedation so long as concentration does not exceed 50% and is NOT used in combo with any other drug Combining one or more enteral drugs with nitrous oxide or use of more than a single enteral drug or administering IV drug = moderate sedation 12

13 Minimal Sedation Additional Issues Cannot bill for non-iv conscious or moderate sedation Advertising must clearly reflect that it is minimal sedation and not be misleading Check Up on Your Sedation Practices What level of sedation are you intending to achieve? Do you have the proper training and permits? Do you have properly trained personnel? Do you have proper equipment in facility? If you are using outside anesthesia professionals, do you have the correct waiver and approval of facility? Additional Check Up Areas Are you advertising properly? (650-26) Are you satisfying all record keeping requirements? ( ) Are you appropriately prescribing, administering and dispensing drugs? (650-16) 13

14 Website: Health Law Blog: Toll Free Phone Number: OFFICE LOCATIONS: 666 Grand Avenue, Suite 2000 Des Moines, Iowa Telephone: (515) Franklin Place Pella, Iowa Telephone: (641) DISCLAIMER: No oral or written statement made by BrownWinick attorneys should be interpreted by the recipient as suggesting a need to obtain legal counsel frombrownwinick or anyother firm, nor as suggesting a need to take legal action. Do not attempt to solve individual problems upon the basis of general information provided by any BrownWinick attorney, as slight changes in fact situations may cause a material change in legal result. 14